Essential documents also serve a number of other important purposes. The timely submission of essential documents to investigator/institutional/sponsor sites can be very helpful to the success of a study by the investigator, sponsor and monitor. These documents are also those that are typically reviewed by the sponsor`s independent audit function and reviewed by the regulator as part of the process to confirm the validity of the study conduct and the integrity of the data collected. During this planning phase, the following documents should be produced and archived prior to the formal commencement of the audit. At the end of the audit, all documents referred to in sections 8.2 and 8.3 must be placed on file with the following documents: The following is the minimum list of essential documents that have been developed. The different documents are divided into three sections, depending on the stage of the study at which they are usually prepared: 1) before the start of the clinical phase of the study, 2) during the clinical conduct of the study, and 3) after the end or end of the study. It describes the purpose of each document and whether it should be filed with the investigator or the institution or sponsor, or both. It is acceptable to combine certain documents, provided that the individual elements are easily identifiable. Informed consent is a process by which a subject voluntarily confirms their willingness to participate in one or another clinical trial after being informed of all aspects of the study.
Informed consent must be documented by a written, signed and dated Informed Consent Form (ICF). Once the objectives and design of a clinical trial have been established, these questions should be documented in the study protocol. The study protocol is a document that contains instructions for all parties involved in the clinical trial, setting specific goals for each participant and providing guidelines for their conduct. The study protocol should ensure the appropriate conduct of clinical trials and the collection and analysis of data submitted to regulatory authorities for review and testing. In addition to the above documents, the following should be added to files during the audit to demonstrate that all relevant new information will be documented as it becomes available. Some or all of the documents referenced in this guidance document may be subject to review by the sponsor`s investigator and inspection by the regulatory authority(ies) and should be made available to them. Draft guidance documents Draft guidance documents have been proposed and will be released for public comment. Each FDA draft lists how comments are submitted to the agency. Terms that may be difficult for study participants to understand (medical and legal terms) should be avoided when translating the above documents containing patient information. If specific terms are used in the documents, these should be clarified or explained.
In this article, we would like to give a brief overview of the essential study documents that most often need to be translated during a clinical trial. We hope this article will be useful for those who are involved in translating clinical trial material because of their activities. Some web links (URLs) embedded in the guides may have changed since the document was published. If you find a link that doesn`t work, try searching for the document using the document title. For more assistance, see Contact the FDA. Baseline study data should be created at the beginning of the study, both at the investigator`s or institution`s site and at the sponsor`s office. A final conclusion of a study can only be made if the controller has reviewed the investigator/institution and sponsor records and confirmed that all required documentation is in the relevant records. The guidance documents, which are included under the umbrella term FDA Information Sheets, represent the agency`s current considerations for the protection of human subjects in research. The date after the title of each document represents the last update for that topic. Many documents were last updated prior to the publication of the Good Practice Guidance requirements.
Therefore, if further updates are required, some documents may need to be reformatted. While most will continue to be included in the fact sheets, some may be accessible separately after the update. The sponsor and the researcher or institution should maintain records of the location of their respective essential documents, including source documents. The storage system used during testing and archiving (regardless of the type of media used) must be capable of document identification, version history, search, and retrieval. Essential documents for the review should be supplemented or reduced if justified (before the start of the review) by the importance and relevance of the specific documents for the review. The sponsor should ensure that the investigator has control and ongoing access to the RTC data provided to him. The sponsor should not have sole control over this data. If a copy is used to replace an original document (e.g. source documents, CRF), the copy must meet the requirements for certified true copies.
The examiner/institution shall have control of all essential documents and records prepared by the auditor or institution before, during and after the test. Contains preclinical and clinical information on an investigational medicinal product. The information must be presented in a concise, simple, objective and balanced form, which must be taken into account in the translation. Let us now take a closer look at these documents: essential documents are those documents which, individually and collectively, make it possible to assess the conduct of a study and the quality of the data produced. These documents are used to demonstrate compliance with standards of good clinical practice and all applicable regulatory requirements by the investigator, sponsor and supervisor. The following sections should be included in the study protocol: The protocol change describes significant changes from the original study protocol. The amendment of the protocol must be approved again by the ethics committee. Potential subjects should be informed of the objectives and methods of the study, the drug and treatment regimen, available alternative treatments, potential risks and benefits, and possible complications and complaints that may arise from participation in the study.
8.2 Before commencing the clinical phase of the trial The investigator`s brochure should be reviewed at least annually and, if necessary, revised in accordance with standard procedures established by the drug development company. Data collected at the study site during a study should be complete and provide truthful and accurate information about what happened to each study participant. Only if the above criteria are met does the study reliably answer questions about the efficacy and safety of the investigational drug. The investigator`s responsibility to report on the progress of the study is not only the responsibility, but the study monitor must also provide written reports of each study visit (monitor report). The opinion is prepared for regulatory authorities by an expert in the relevant field (entrepreneur or self-employed person) and covers various aspects of drug development. Based on the information received and understood, the potential subject voluntarily agrees to participate in a study. Informed consent should not be obtained by inducement or coercion. The subject should be aware that he or she may withdraw from the study at any time, which does not affect his or her future medical care. The following appendices may be included in the study protocol: patient information sheet/written information and/or informed consent (ICF). Information sheet (e.g. for study subjects or staff). The case file form is a paper or electronic document that records all the information required in the study protocol for an individual study topic.
Informed consent is one of the most important elements of the system that ensures the ethics of medical experiments and the protection of the rights of study participants. The investigator must submit written reports on the progress of the study to the ethics committee. This may include the interim report on the interim results of the study and their evaluation based on the analysis conducted during the study, or the final report – a complete and complete description of the study, including the description of the study material, the design of the study, and the presentation and evaluation of the results of the statistical analysis. In addition, the investigator should prepare written reports of any significant changes that could affect the conduct of the study and/or increase the risk to study participants. These include: adverse event report or adverse drug reaction report, patient entry form (patient admission card/patient notification form) and patient withdrawal form, deviation/protocol violation report, study discontinuation report, etc. The investigator`s brochure shall include a title page containing the name of the sponsor, the identity of the investigational device(s), an edition number and date, and the number and date of issue replacing it. The sponsor may attach a confidentiality agreement directing the International Bureau to be treated as a confidential document.
